The whole furore around GDPR came and went during 2018. Like most businesses we put a fair amount of effort and time into working out how best to meet the new rules, opting customers in, updating privacy policies, etc. Yet I’m not convinced it will make much difference. The issue for British Airways in the second half of 2018 highlights how sophisticated hackers are in breaching modern systems and surely this is the real risk for personal data, not the use of outdated mailing or telephone lists. I was affected by the BA issue and decided to cancel my credit card, which of course caused separate issues. So, I ask myself what was the point of GDPR? Good companies, like ourselves, were already doing the right things, bad companies will continue to flaunt the rules and probably get away unpunished. A radio interview with the Deputy Commissioner didn’t exactly fill me with confidence that the ICO will have any greater impact!
GDPR may have faded into the background, but Brexit is still large and central. It is now less than 2 months until the deadline for the UK to leave the European Union. At 11pm on 29th March we exit – I wonder if there will be a countdown, much like New Year’s Eve! The UK government is in turmoil and yet to present an acceptable withdrawal agreement; whether it will be a hard, soft or a no deal Brexit, whether we should adopt WTO rules, or anything else. The advice and guidance for SME’s like us is in short supply and worrying. And like most I’m sure customers are starting to ask questions about your plans. I am pleased that we invested the time and effort in compiling a business continuity plan. Whilst it can’t answer the specific risks associated with the as yet unknown impact of Brexit, I believe it provides a suitable framework for us to use. I am also convinced that seeking out good information from organisations, such as Chambers of Commerce, will be vital as 29 March 2019 gets closer.
The other major news within our sector has been the ongoing debate around the revised GMP Annex 1. First published back in 1971, Annex 1 was last revised in 2008. The latest revision is the most comprehensive in its history and unsurprisingly has caused much debate at meetings and events, long after the consultation deadline closed in March 2018. The publication date for the agreed revision is, as I write, no clearer. And yet I do wonder if the regulators and inspectors have already adopted the new version, in fact many of the changes have come about because that was already happening.
With both Brexit and Annex 1, I wonder if the impact of both will be quite as severe as is predicted. Are the perceived shock waves going to be anywhere near as bad as we think? Will in fact most businesses just get on with dealing with any fallout in a pragmatic and diligent way. The markets have already factored in any impact from Brexit, the regulators are already imposing the new state on pharma manufacturers, so what’s to worry about? That may be a simplistic view and there may well be some short-term disruption, so how can we help? As with any period of change, we need good advice, but just as important we need to communicate regularly. It was very pleasing to hear comments from one of our major customers, they said “Cherwell are one of the most communicative suppliers we have.” We have always held the principle that good news or bad, let’s talk about it and find a solution.
We value the opportunity to discuss your requirements and are always happy to work with you to provide solutions. So, please feel free to contact us.
NEW! Revised Environmental Monitoring Process and Validation Guide
How are you going to meet the challenge of the new EU GMP Annex 1?
Our revised and updated guide helps highlight decisions and actions to ensure you remain compliant.